Table 1.
Study quality based on criteria for evaluation of a novel biomarker.
| Novel marker reported: | Reiter [ 9 ] | Viswanathan [ 12 ] | McCann [ 11 ] | Ilva [ 14 ] | Kilcullen [ 7 ] | O’Donoghue [ 13 ] | Ishii [ 10 ] |
|---|---|---|---|---|---|---|---|
| In accordance with STROBE [19] | ++ | ++ | ++ | + | ++ | ++ | ++ |
| a) Standard RF, and b) results of risk model using established factors |
+++ - |
+++ +++ |
+++ ++ |
+++ ++ |
+++ +++ |
+++ +++ |
+++ +++ |
| a) RR, OR, HR with CI/p value b) RR, OR, HR adjusted for RF and CI/p value c) p value for addition of novel marker to standard risk markers. |
- +++ - |
+++ +++ +++ |
+++ +++ +++ |
- - - |
+++ +++ +++ |
+++ +++ - |
+++ +++ +++ |
| a) C-index and CL for model with established risk markers b) C-index and CL for model including novel and established risk markers c) Discrimination index/slope or binary R2 for model with and without novel marker. d) Graphic display of predicted cases before and after inclusion of the marker. |
+ + - - |
+ + - - |
- - - - |
- - - - |
- - - - |
- - - - |
+ + - - |
| a) Display observed vs. expected event rates without/ with the novel risk marker. b)using generally recognised risk thresholds, subjects reclassified and event rates in reclassified groups |
- - |
- - |
- - |
- - |
- - |
- - |
- - |
| Clearly defined aim | Good | Fair | Good | Good | Good | Good | Good |
| ‘real-life’ population | Good | Good | Good | Good | Fair | Fair | Good |
| Appropriate sampling period for HFABP release | - | Yes | Yes | Yes | Yes | No | - |
+++ Complete adherence, ++reasonable adherence, +partial adherence, - does not report
RF risk factors, CI Confidence interval, CL confidence limits.